Miles Laboratories, Inc. v. Doe

MURPHY, Chief Judge. These cases present questions of Maryland law certified to us by the United States District Court for the District of Maryland, pursuant to the Uniform Certification of Questions of Law Act, Md.Code (1974, 1984 Repl.Vol.), §§ 12-601 through 12-609 of the Courts and Judicial Proceedings Article. 1 Each case draws into question the liability of a supplier of blood or blood products alleged to have transmit ⁷⁰⁸ ted the Acquired Immune Deficiency Syndrome (the AIDS virus) to the plaintiff-recipients. 2 I. Miscellaneous No. 1 involves a suit against Miles Laboratories, Inc. (Miles), a commercial preparer and supplier of “Konyne” — a blood clotting factor concentrate. Plaintiffs Jane and John Doe, in a multi-count complaint filed in the federal district court, have alleged a cause of action against Miles, inter alia, in strict liability, implied warranty, and negligence. As certified by the district court, the facts jointly agreed upon by the parties are essentially these: Jane Doe delivered a child in September of 1983.

Several days later she was admitted to Shady Grove Adventist Hospital suffering from profuse vaginal bleeding. Her bleeding could not initially be controlled although she was given substantial amounts of blood derivatives. In total, approximately 46-50 units of various blood derivatives were made available for transfusion into Mrs. Doe, although not all may have been given. During the attempt to stop the bleeding, her physicians administered a single “500 unit” vial of “Konyne” to Mrs. Doe.

Ultimately, her bleeding stopped. Subsequently Mrs. Doe developed a variety of health problems which assertedly led to the diagnosis of HIV (Human Immunodeficiency Virus) — the “AIDS” virus — and the diagnosis of ARC (Acquired Immunodeficiency Related ⁷⁰⁹ Complex). 3 Mrs. Doe has not been diagnosed as having actual AIDS, although there is a substantial risk that she may contract full-blown AIDS at some time in the future. Miles purchases the blood plasma necessary for the preparation of Konyne from blood donors. It markets Konyne to hospitals and doctors; it does not administer the product to anyone.

In this case, Miles provided Konyne to the Washington Hospital Center which in turn provided the particular vial administered to Mrs. Doe to the Shady Grove Adventist Hospital. The Konyne received by Mrs. Doe in September of 1983 was shipped by Miles in January of 1983. 4 A. By Chapter 717 of the Acts of 1971, then codified as Maryland Code (1957, 1980 Repl.Vol.), Art. 43, § 136B, the General Assembly provided: “As to the virus of serum hepatitis, neither strict liability in tort nor the implied warranties of merchantability and fitness shall be applicable to the procurement, processing, storage, distribution, and/or use of whole blood, plasma, blood products, and blood derivatives for the use of injection or transfusing the same or any of them into the human body for any purpose whatsoever.” (Emphasis supplied) Chapter 21 of the Acts of 1982 added the Health-General Article to the Maryland Code. It repealed § 136B; in its place, it enacted § 18-402 which provided: ⁷¹⁰ “A person who obtains, processes, stores, distributes or uses whole blood or any substance derived from blood for injection or transfusion into an individual for any purpose may not be held liable for the virus of serum hepatitis under: (1) Strict liability in tort; (2) The implied warranty of merchantability; or (3) The implied warranty of fitness.” (Emphasis supplied) The revisor’s note to § 18-402 stated that its provisions were derived without substantive change from former § 136B. Section 18-402 was substantially amended by Chapter 259 of the Acts of 1986 (the 1986 amendment) to read: “A legally authorized person who obtains, processes, stores, distributes, or uses whole blood or any substance derived from blood for injection or transfusion into an individual for any purpose is performing a service and is not subject to: (1) Strict liability in tort; (2) The implied warranty of merchantability; or (3) The implied warranty of fitness.” The Legislature provided that the 1986 amendment to § 18-402 would take effect on July 1, 1986. 5 (1) The first certified question is whether the provisions of § 18-402, as amended in 1986, “exempt the commercial ⁷¹¹ preparer and supplier of a blood product from strict liability in tort where, assertedly as a result of the blood product, the recipient was infected with the AIDS virus prior to 1986.” The 1986 amendment to § 18-402 eliminated the reference in the precursor statutes to the virus of serum hepatitis.

It broadly insulated blood or blood product suppliers from strict liability in tort and from breach of the implied warranties of merchantability and fitness “for injection or transfusion into an individual for any purpose”; and it characterized this activity as a “service” (rather than a sale). The Does acknowledge that the 1986 amendment to § 18-402 abrogated a strict tort liability cause of action against blood product suppliers for all transfusion-associated diseases. They point out that Mrs. Doe was transfused in September of 1988, well prior to the July 1,1986 effective date of the amendment to § 18-402 and, also, that suit was filed prior to July 1, 1986. The Does claim that the pre1986 blood shield statutes in effect when Mrs. Doe was infected with the AIDS virus, and at the time suit was filed, precluded recovery against a blood product manufacturer in strict liability in tort or breach of implied warranties only when the person contracted serum hepatitis.

The Does contend that there is nothing in the history of the 1986 amendment to indicate a legislative intention that the statute be retroactively applied. Moreover, they invite attention to the report of the Senate Judicial Proceedings Committee which recognized that the 1986 amendment “expands” the scope of the exemption from liability by repealing “the limiting reference to the virus of serum hepatitis.” From this the Does glean an intention that blood suppliers would remain liable without fault with respect to all pre1986 transfusions resulting in disease or contaminants other than the virus of serum hepatitis. Miles argues that the 1986 amendment was intended by the Legislature to apply to all cases of AIDS infection resulting from the use of blood products, regardless of the ⁷¹² date of the infection or the date upon which suit is filed. It says that the legislative history and context of the 1986 amendment shows that limiting it to prospective operation would be inconsistent with the legislative purpose.

It suggests that because the AIDS virus was not isolated until 1984, and there was no test to detect the presence of the AIDS virus in the blood supply until 1985, the focus of the 1986 amendment was necessarily upon pre-1986 cases. Miles maintains that the Legislature, in dealing with such a significant public policy matter, could only have intended that the 1986 amendment be given retroactive application to include the vast majority of blood-related AIDS cases in which infection occurred prior to 1986. According to Miles, there could be no reason for the Legislature, in enacting the 1986 amendment, to create any distinction between those infected persons who discovered their infection and brought suit prior to July 1, 1986, and those who could not sue before that date because they had not yet discovered their infection. We view the legislative history underlying enactment of the 1986 amendment as inconclusive at best.

In these circumstances, the Maryland rule, most recently reaffirmed by Judge Rodowsky for the Court in WSSC v. Riverdale Heights Volunteer Fire Co. Inc., 308 Md. 556 , 520 A.2d 1319 (1987), is that the statute is presumed to operate prospectively and should be construed accordingly. As we said in that case, while there is no absolute bar to retrospective application, “The presumption against retrospectivity is rebutted only where there are clear expressions in the statute to the contrary” and only upon “the plainest mandate in the legislation.” 308 Md. at 561 , 520 A.2d 1319 . The rationale underlying this rule “provides that retrospective application, which attempts to determine the legal significance of acts that occurred prior to the statute’s effective date, increases the potential for interference with persons’ substantive rights.” Id. After a thorough review of the history of § 18-402, the Court of Special Appeals, in Roberts v. Suburban Hospital, ⁷¹³ 73 Md.App. 1 , 532 A.2d 1081 (1988) held that there was no indication that the Legislature in its 1986 amendment to § 18-402, intended that it be retroactive.

The same conclusion was reached by the federal district court in Doe v. Miles Laboratories, Cutter Laboratories Div., 675 F.Supp. 1466 (D.Md.1987). In that case, the court concluded on authority of the Riverdale case that because there was no clear expression by the Legislature that it intended the 1986 amendment to relate back to provide immunity for a 1983 transfusion which allegedly resulted in the transmission of the AIDS virus, the 1986 amendment was not applicable. Finding no clear expression of an intention that the 1986 amendment was to be retrospective, we answer the first certified question in the negative. (2) The second certified question is whether § 18-402, prior to its amendment in 1986, “exempt[s] the commercial preparer and supplier of a blood product from strict liability in tort where, assertedly as a result of receipt of the blood product, the recipient was infected with the AIDS virus.” The Does argue that the legislative history of the pre1986 blood shield statute discloses that the General Assembly, in the plainest of words, limited the immunity from transfusion-associated disease to the virus of serum hepatitis.

Miles, on the other hand, argues that § 18-402, even before its amendment in 1986, was applicable to all pathogens which, like serum hepatitis and the AIDS virus, could not be detected or eliminated from blood products. According to Miles, the public policy considerations that led the Legislature in 1971 to enact the original version of § 18-402 are equally applicable to AIDS cases. It urges that “the pre-amendment version of § 18-402 merely expresses the General Assembly’s intent to limit that provision to those infectious agents that cannot be detected by reasonably available scientific techniques.” We think the applicable history clearly demonstrates that the Legislature intended that the original version of what is now § 18-402, as enacted in 1971 and as recodified in 1982, ⁷¹⁴ apply solely to the disease of serum hepatitis. The Court of Special Appeals, in Roberts , and the federal district court in Doe v. Miles Laboratories, supra, both made clear that the limited application of the pre-1986 legislation to the serum hepatitis contaminant was deliberate.

As stated by Judge Wilner for the court in Roberts, 73 Md.App. at 9 , 532 A.2d 1081 , as originally proposed the 1971 Bill “would have exempted all transfusions from the doctrine of strict liability and implied warranty and declared them generally to constitute the rendering of a service rather than a sale, but, during the legislative process, the General Assembly struck out that general language and restricted the exemption” [to the virus of serum hepatitis]. 6 It is thus plain that, as originally introduced, the 1971 version of what is now § 18-402 was all-encompassing in its terms; its shield was not limited to serum hepatitis and it characterized the provision of blood as a “service.” Had the Legislature enacted the bill in this form it clearly would have included AIDS or any other as then unknown diseases that might be transmitted through blood. In view of the clarity of the legislative purpose in amending the Bill, it would be a forced interpretation indeed for us to expand the scope of the pre-1986 statutes to include the AIDS or any other infectious virus. We therefore answer the second certified question in the negative. (3) If § 18-402 is not applicable in either its original or amended form, the third certified question asks whether ⁷¹⁵ “Maryland common law, and/or the Restatement (Second) of Torts, Section 402A, and its Comments, permit recovery from the commercial preparer and supplier (not health care provider) of a blood product, based on the theory of strict liability in tort, where, assertedly as a result of receipt of the blood product, the recipient was infected with the AIDS virus?” In 1976, for the first time in Phipps v. General Motors Corp., 278 Md. 337 , 363 A.2d 955 (1976), we adopted the doctrine of strict liability in tort, as expressed in § 402A of the Restatement (Second) of Torts. 7 That section provides: “Special Liability of Seller of Product for Physical Harm to User or Consumer “(1) One who sells any product in a defective condition unreasonably dangerous to the user or consumer or to his property is subject to liability for physical harm thereby caused to the ultimate user or consumer, or to his property, if (a) the seller is engaged in the business of selling such a product, and (b) it is expected to and does reach the user or consumer without substantial change in the condition in which it is sold. “(2) The rule stated in Subsection (1) applies although (a) the seller has exercised all possible care in the preparation and sale of his product, and (b) the user or consumer has not bought the product from or entered into any contractual relation with the seller.” We pointed out in Phipps, 278 Md. at 346 , 363 A.2d 955 , that we had never theretofore rejected the strict liability theory of § 402A as a basis of liability; rather, we had declined in earlier cases to adopt the strict liability principles of § 402A because, under the facts of those cases, ⁷¹⁶ § 402A was not applicable and would have afforded no additional basis of liability.

See, e.g., Frericks v. General Motors Corp., 274 Md. 288 , 336 A.2d 118 (1975); Volkswagen of America v. Young, 272 Md. 201 , 321 A.2d 737 (1974); Myers v. Montgomery Ward & Co., 253 Md. 282 , 252 A.2d 855 (1969); Telak v. Maszczenski, 248 Md. 476 , 237 A.2d 434 (1968). In Phipps , we rejected the argument that the adoption of strict liability in Maryland should be left to the Legislature. Id. 278 Md. at 349 , 363 A.2d 955 . Writing for the Court, Judge Eldridge noted in Phipps that the Official Reporter’s Notes to § 402A indicated that the section “was based upon a developing body of case law expanding the liability of manufacturers for injury caused by defective products.” Id. at 341, 363 A.2d 955 .

The strict liability theory, we said, was essentially an action in tort dispensing with the traditional requirement of privity in contract actions. Id. at 342 , 363 A.2d 955 . We summarized its elements, as contained in § 402A, in these words: “For recovery, it must be established that (1) the product was in a defective condition at the time that it left the possession or control of the seller, (2) that it was unreasonably dangerous to the user or consumer, (3) that the defect was a cause of the injuries, and (4) that the product was expected to and did reach the consumer without substantial change in its condition.” Id. at 344, 363 A.2d 955 . We recognized that the plaintiff in a strict liability action need not prove any specific act of negligence on the part of the seller, since the inquiry in such an action “focuses not on the conduct of the manufacturer but rather on the product itself.” Id. at 344 , 363 A.2d 955 .

We said that, for a seller to be liable under § 402A, the product must be both in a “defective condition” and “unreasonably dangerous” at the time it is placed on the market by the seller. Id. Both of these conditions, we observed, were explained in the official comments to § 402A in terms of consumer expectations. Comment g, in explaining the requirements of a “defective condition,” limits § 402A to those situations ⁷¹⁷ where “the product is, at the time it leaves the seller’s hands, in a condition not contemplated by the ultimate consumer, which will be unreasonably dangerous to him.” Id.

Comment i defines an “unreasonably dangerous” product as one which is “dangerous to an extend beyond that which would be contemplated by the ordinary consumer who purchases it, with the ordinary knowledge common to the community as to its characteristics.” Id. The theory of strict liability, we said in Phipps , was not a radical departure from traditional tort concepts, even though the plaintiff in such an action need not prove any specific act of negligence on the part of the seller. Id. at 351 , 363 A.2d 955 . What is required is proof of a defect existing in the product at the time it leaves the seller’s control.

Id. Under strict liability principles, the seller is not an insurer, as absolute liability is not imposed on the seller for any injury resulting from the use of his product. Id. at 352 , 363 A.2d 955 . Rather, “[pjroof of a defect in the product at the time it leaves the control of the seller implies fault on the part of the seller sufficient to justify imposing liability for injuries caused by the product.” Id.

The various justifications for imposing strict liability in tort on manufacturers are set forth in Comment c to § 402A as follows: “... the justification for the strict liability has been said to be that the seller, by marketing his product for use and consumption, has undertaken and assumed a special responsibility toward any member of the consuming public who may be injured by it; that the public has the right to and does expect, in the case of products which it needs and for which it is forced to rely upon the seller, that reputable sellers will stand behind their goods; that public policy demands that the burden of accidental injuries caused by products intended for consumption be placed upon those who market them, and be treated as a cost of production against which liability insurance can be obtained; and that the consumer of such products is entitled to the maximum of protection at the hands of ⁷¹⁸ someone, and the proper persons to afford it are those who market the products.” Thus, in adopting strict liability in tort in Maryland, we concluded that there was no reason “why a party injured by a defective and unreasonably dangerous product, which when placed on the market is impliedly represented as safe, should bear the loss of that injury when the seller of that product is in a better position to take precautions and protect against the defect.” Id. at 352-353, 363 A.2d 955 . Miles contends that § 18-402, as amended in 1986, derives from the common law of Maryland, namely that “provision of blood products is, in all cases, a service, not a sale, and strict liability does not apply.” The leading case representative of this common law view, according to Miles, is Perlmutter v. Beth David Hospital, 308 N.Y. 100 , 123 N.E.2d 792 (1954). There, the plaintiff received a blood transfusion containing hepatitis virus and sued the hospital for breach of the implied warranties of fitness and merchantability under New York’s Sales Act. No claim of strict liability in tort was made.

The court viewed the contractual relationship between hospital and patient as one for services and thus it rejected the argument that a blood-transfusion was a sale of goods subject to implied warranties. It held, 123 N.E.2d at 795 : “The supplying of blood by the hospital was entirely subordinate to its paramount function of furnishing trained personnel and specialized facilities in an endeavor to restore plaintiffs health. It was not for blood — or iodine or bandages — for which plaintiff bargained, but the wherewithal of the hospital staff and the availability of hospital facilities to provide whatever medical treatment was considered advisable. The conclusion is evident that the furnishing of blood was only an incidental and very secondary adjunct to the services performed by the hospital and, therefore, was not within the provisions of the Sales Act. ⁷¹⁹ If ... the court were to stamp as a sale the supplying of blood — or the furnishing of other medical aid — it would mean that the hospital, no matter how careful, no matter that the disease-producing potential in the blood could not possibly be discovered, would be held responsible, virtually as an insurer, if anything were to happen to the patient as a result of ‘bad’ blood.” Miles points out that the Court of Special Appeals in Roberts, supra, 73 Md.App. at 11, 532 A.2d 1081 noted, with an extensive citation of authority, that the Perlmutter view was the majority rule with respect to suits against hospitals based on the actual transfusion of blood.

Miles further contends that, if the provision of blood products by a blood supplier instead of a hospital is considered a sale, it cannot be held strictly liable because such products are “unavoidably unsafe” within the contemplation of Comment k to § 402 A of the Restatement which provides: “k. Unavoidably unsafe products. There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs.

An outstanding example is the vaccine for the Pasteur treatment of rabies, which not uncommonly leads to very serious and damaging consequences when it is injected. Since the disease itself invariably leads to a dreadful death, both the marketing and the use of the vaccine are fully justified, notwithstanding the unavoidable high degree of risk which they involve. Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous. The same is true of many other drugs, vaccines, and the like, many of which for this very reason cannot legally be sold except to physicians, or under the prescription of a physician.

It is also true in particular of many new or experimental drugs as to which, because of lack of time and opportunity for sufficient medical experience, there can be no assurance of ⁷²⁰ safety, or perhaps even of purity of ingredients, but such experience as there is justifies the marketing and use of the drug notwithstanding a medically recognizable risk. The seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk.” Miles argues that in Phipps we adopted § 402 A of the Restatement, together with its official comments, and thereby made clear that where a product is “unavoidably unsafe,” it is not subject to strict liability. Miles claims that Comment k applies to blood and blood products. The Does contend that public policy in Maryland until July 1, 1986, as established by the Legislature, sanctioned strict liability actions in all blood product cases except those where the transfusion implicated the serum hepatitis virus.

They argue that under Maryland common law, and § 402A, Miles — as a commercial manufacturer and seller of the blood derivative Konyne — is subject to strict liability if its product was in a defective condition and unreasonably dangerous at the time it was placed on the market. In this regard, the Does say that whether a transaction is a service or a sale for purposes of § 402 A is determined by the so-called “gravamen test” articulated in Anthony Pools v. Sheehan, 295 Md. 285, 298 , 455 A.2d 434 (1983), namely “... that where, as part of a commercial transaction, consumer goods are sold which retain their character as consumer goods after completion of the performance promised to the consumer, and where monetary loss or personal injury is claimed to have resulted from a defect in the consumer goods, the provisions of the Maryland Uniform Commercial Code dealing with implied warranties apply to the consumer goods, even if the transaction is predominately one for the rendering of consumer services.” Applying ⁷²¹ this test, the Does claim that Miles’ sole purpose is to sell its products at a profit; and that as it does not administer Konyne, it played no part in the health care of Mrs. Doe. The gravamen of their action against Miles, they say, arises from an injury which resulted from receiving a defective and unreasonably dangerous blood product and not from the product’s negligent administration or infusion. Thus, maintain the Does, Miles’ commercial sale of the blood to the Washington Hospital Center, with a further sale to Shady Grove Adventist Hospital and then to Jane Doe, constitutes a sale and not a service.

The Does maintain that cases involving strict liability actions against hospitals for administering blood transfusions are not relevant since hospitals, unlike blood suppliers, are engaged in providing health services and not in selling blood products. The Does point out that, under § 402A, it makes no difference that Miles may have exercised all possible care in the preparation and sale of Konyne or that AIDS may not have been detectable in blood or blood products at the time of the sale in this case. The only issue, according to the Does, is whether the defective blood product was unreasonably dangerous, not whether the manufacturer exercised all possible care in its preparation. The Does argue that the “unavoidably unsafe” formulation of Comment k to § 402 A does not shield Miles from strict tort liability.

They suggest that we have never adopted Comment k in this State but that if we do it is an affirmative defense which shifts the burden of proof to the defendant to establish all of the conditions justifying the application of Comment k. Relying primarily upon Belle Bonfils Memorial Blood Bank v. Hansen, 665 P.2d 118 (Col.1983), the Does maintain that the threshold factors which may justify a product’s exception from strict liability are: (1) the product’s utility must greatly outweigh the risk created by its use; (2) the risk must be a known one; (3) the product’s benefits must not be achievable in another manner; and (4) the risk must be unavoidable under the present state of knowledge. Based on evidence adduced before the ⁷²² district court in this case, the Does urge us to declare, as a matter of law, that Miles cannot establish any of these factors and thus is strictly liable in tort for the injury here involved. 8 In determining whether Comment k to § 402 A was part of the common law of Maryland in 1983 when the injury occurred in this case, we first note that the seminal case adopting strict liability in tort was Greenman v. Yuba Power Products, Inc., 59 Cal.2d 57 , 27 Cal.Rptr. 697 , 377 P.2d 897 (1963). Two years later, the essential principles enunciated in that case were codified by The American Law Institute as § 402 A of the Restatement.

In that same year, the author of the Greenman opinion, Chief Justice Traynor of the Supreme Court of California, warned against over-inclusiveness in applying the strict liability doctrine. He noted that the “unavoidably unsafe products” formulation of Comment k guarded against this possibility and he characterized blood as “a classic example” of such a product. See Traynor, The Ways and Meanings of Defective ⁷²³ Products and Strict Liability, 32 Tenn.L.Rev. 363, 367 (1965). The first case which pressed the theory of strict liability in tort upon us was Telak v. Maszczenski, 248 Md. 476 , 237 A.2d 434 (1968); it involved a permanent injury sustained by an individual as a result of a diving board accident.

Referring to Prosser, The Fall of the Citadel (Strict Liability to the Consumer) 50 Minn.L.Rev. 791, 793-94 (1966), we recognized that “the doctrine of strict liability, irrespective of fault, [was as] set forth in § 402 A of the Restatement.” 248 Md. at 488 . In declining to adopt the doctrine in that case, we said that “[w]hatever we may be persuaded to do in the future in this regard, we find it unnecessary, at this time, to espouse the cause of strict liability.” Id. at 488 , 237 A.2d 434 . Schuchman v. Johns Hopkins Hospital, Prod.Liab.Rptr. CCH # 6557 (1970-78 Transfer Binder), 9 UCC Reporting Service 637, decided January 21, 1971, involved claims against a hospital for strict liability in tort and breach of implied warranties following a blood transfusion which transmitted the hepatitis virus to the patient.

The Superior Court of Baltimore City (O’Donnell, J), after an extensive analysis of the cases, including Perlmutter and its progeny, concluded that a blood transfusion administered by a hospital was a service and not a sale; consequently, it dismissed the strict liability and warranty counts as not within § 402 A or the then applicable provisions of the Uniform Commercial Code. The 1971 precursor to § 18-402 was enacted shortly after the Schuchman case was decided. As strict liability in tort was not then part of the common law of Maryland, the 1971 statute, not being inconsistent with the common law, did not alter or modify that law. Nor was the 1971 statute intended to preempt the common law by subjecting all suppliers of blood and blood products to strict liability in tort and implied warranty claims for all transfusion-associated diseases except the virus of serum hepatitis.

In this ⁷²⁴ regard, we note that repeal of the common law by implication is never favored. See Hardy v. State, 301 Md. 124, 181 , 482 A.2d 474 (1984); Lutz v. State, 167 Md. 12, 15 , 172 A. 354 (1934). As hepatitis was the known transfusion-transmitted disease of concern to the Legislature when it enacted the 1971 statute, it is likely that the statute’s enactment was inspired by legislative apprehension that Maryland courts might adopt the strict liability doctrine and apply it to suppliers of blood and blood products. Our adoption of § 402 A in Phipps in 1976 constituted a change in the common law of Maryland by judicial decision, a course of action we are authorized to take when, in light of changed conditions or increased knowledge, the former rule has become unsound in the circumstances of modern life.

See Ireland v. State, 310 Md. 328 , 529 A.2d 365 (1987); Kelley v. R. G. Industries, Inc., 304 Md. 124 , 497 A.2d 1143 (1985); Harrison v. Mont. Co. Bd. of Educ., 295 Md. 442 , 456 A.2d 894 (1983). In Phipps , we implicitly adopted the substance of Comment k. 9 Therefore, where a sale of a product is involved, but Comment k applies, the doctrine of strict liability in tort has no application. It is undisputed that Konyne is a prescription product available only through a licensed physician; it is sold by Miles to hospitals and physicians.

Needles and syringes necessary to administer Konyne are available at licensed pharmacies and injections of the product can be made in the home after a patient or a family member has been trained by a health care professional. Either under the “gravamen test” of Anthony Pools, supra, 295 Md. at 298, 455 A.2d 434 , or the “predominant purpose” test of Burton v. Artery ⁷²⁵ Company, 279 Md. 94 , 367 A.2d 935 (1977), 10 Miles’ preparation and supplying of Konyne under Maryland common law principles in 1983 constituted a sale, rather than a service, and hence the provisions of § 402 A and Comment k are applicable. Blood and blood products have been found to be “unavoidably unsafe” under Comment k in a number of cases. See Fogo v. Cutter Laboratories, 68 Cal.App.3d 744 , 137 Cal.Rptr. 417 (1977); Fisher v. Sibley Memorial Hospital, 403 A.2d 1130 (D.C.App.1979); McMichael v. American Red Cross, 532 S.W.2d 7 (Ky.1975); Brody v. Overlook Hospital, 127 N.J.Super. 331 , 317 A.2d 392 (1974) aff’d 66 N.J. 448 , 332 A.2d 596 (1975); Moore v. Underwood Memorial Hospital, 147 N.J. Super. 252 , 371 A.2d 105 (1977); Hines v. St. Joseph’s Hosp., 86 N.M. 763 , 527 P.2d 1075 (1974).

See also Brown v. Superior Court (Abbott Laboratories), 44 Cal.3d 1049 , 245 Cal.Rptr. 412 , 751 P.2d 470 (1988) in which the Supreme Court of California held that Comment k was applicable to all prescription medical products; McKee v. Cutter Laboratories, 866 F.2d 219 (6th Cir.1989); Annot., Liability of Blood Supplier or Donor for Injury or Death Resulting from Blood Transfusion, 24 A.L.R. 4th 508 -540 (1983) and particularly § 41(c) (“Blood Transfusion as unavoidably unsafe product”); V. Schwartz, Unavoidably Unsafe Products: Clarifying The Meaning and Policy Behind Comment K., 42 Wash, and Lee L. Rev. 1189 (1985). The cases which find blood and blood products to be unavoidably unsafe and thus within the ambit of Comment k mainly involve the hepatitis virus. They recognize the critical importance of these products to the health of the citizenry and the public interest in assuring their ready availability for medical treatment. These cases generally note that where the viral agent which contaminated the ⁷²⁶ blood was undetectable by any known scientific test at the time of the injury, the product’s great utility, its lack of any substitute, and its relatively small risk of transmitting the disease, renders it not “unreasonably dangerous” for its intended use.

In Belle Bonfils Memorial Blood Bank v. Hansen, supra, the question before the Supreme Court of Colorado was whether the Comment k exception to strict liability for unavoidably unsafe products applied to transfused blood contaminated with hepatitis virus. The court said that under Comment k, “the manufacturer or seller of a product which is vitally important yet unavoidably unsafe is not held strictly liable when it can prove that the product’s preparation, marketing, and accompanying warnings were carried out in conformance with the highest known scientific and technical standards.” 665 P.2d at 120 . The court, upon its finding that there was evidence of an unavoidable risk of hepatitis associated with blood transfusions at the time of the injury, said that the risk was commonly known in the medical profession and incapable of being eliminated. Id.

It observed that Comment k, by its illustrations, “was intended to apply to drugs and medical products.” Id. at 122 . To come within Comment k, the court said that the product must “carry a unique or profound benefit [which] extendfs] to the vast majority of the users of the product,” id. at 123 ; and that the risk must be known to the manufacturer at the time of distribution, knowledge of the product’s dangerous tendencies being imputed to it and a warning required. Id. The court explained that in the case of hepatitis-contaminated blood, the known risk is that “of the potential danger involved in a unit of blood, not the exact condition of any particular unit.” (emphasis in original) Moreover, the court said that the manufacturer must demonstrate “that at the time of the preparation or marketing of the product, the state of the art had not progressed to where the risk was no longer unavoidable, and that the product’s benefits could not be achieved by a substitute product or in another manner.” Id. ⁷²⁷ In light of these factors, the court in Belle Bonfils commented, id. at 124 , that “when a patient needs a blood transfusion, there is no real choice on the part of a physician to order it, a hospital or blood bank to supply it, or a patient to accept it.” Id.

In this connection, the court remarked that the “raison d’etre of strict liability is to force some hazardous products out of the market,” a rationale which it found inapplicable to blood, a lifesaving product